INmune Bio Provides Update Regarding Global Alzheimer’s Phase II Clinical Trial and Clinical Hold Issued by the United States FDA
18 Dezember 2023 - 10:01PM
INmune Bio Inc. (NASDAQ: INMB) (the
“Company”), a clinical-stage immunology company targeting
microglial activation and neuroinflammation as a cause of
Alzheimer’s disease (AD) with XProTM (XPro1595; pegipanermin), a
dominant-negative inhibitor of soluble TNF, is on track to complete
enrollment of its Phase II clinical trial in patients with early
Alzheimer’s Disease and biomarkers of inflammation in 2024. The
Company received notification by the FDA that the US Phase II trial
remains on full clinical hold pending a request for additional
information on long-term potency.
The request came following the most recent submission to the FDA
that showed a possible increase in the long-term potency of XProTM.
The Company will provide clarification to the FDA in a response
before the end of the year that it believes will resolve the
remaining questions. “We remain discussion with the FDA regarding
the clinical hold,” said RJ Tesi, CEO of INmune Bio. “The hold will
not impact our progress in completing the Phase II AD study on
schedule, as our patient recruitment projections are solely reliant
on sites outside of the US.”
The trial is open in Australia, Canada, the United Kingdom,
Poland, France, Spain and is expected to open soon in several
additional EU countries. To date, the FDA remains the only
regulatory agency to put the Phase II clinical trial on hold.
About INmune Bio Inc.
INmune Bio Inc. is
a publicly traded (NASDAQ: INMB), clinical-stage biotechnology
company focused on developing treatments that target the innate
immune system to fight disease. INmune Bio has two product
platforms that are both in clinical trials: The Dominant-Negative
Tumor Necrosis Factor (DN-TNF) product platform utilizes
dominant-negative technology to selectively neutralize soluble TNF,
a key driver of innate immune dysfunction and a mechanistic driver
of many diseases. XProTM is in a blinded randomized placebo
controlled clinical trial to treat Early Alzheimer’s disease in
patients with biomarkers of neuroinflammation. The Natural Killer
Cell Priming Platform, INKmune™, primes patient’s NK cells to
eliminate minimal residual disease in patients with cancer. INKmune
is in early phase clinical trials in MDS/AML and metastatic
Castration Resistant Prostate Cancer. INmune Bio’s product
platforms utilize a precision medicine approach for the treatment
of a wide variety of hematologic and solid tumor malignancies, and
chronic inflammation. To learn more, please
visit www.inmunebio.com.
Forward Looking Statements
Clinical trials are in early stages and there is no assurance
that any specific outcome will be achieved. Any statements
contained in this press release that do not describe historical
facts may constitute forward-looking statements as that term is
defined in the Private Securities Litigation Reform Act of
1995. Any statements contained in this press release that do
not describe historical facts may constitute forward-looking
statements as that term is defined in the Private Securities
Litigation Reform Act of 1995. Any forward-looking statements
contained herein are based on current expectations but are subject
to a number of risks and uncertainties. Actual results and the
timing of certain events and circumstances may differ materially
from those described by the forward-looking statements as a result
of these risks and uncertainties. INB03™, XPro1595 (XPro™), and
INKmune™ are still in clinical trials or preparing to start
clinical trials and have not been approved by the US Food and Drug
Administration (FDA) or any regulatory body and there cannot be any
assurance that they will be approved by the FDA or any regulatory
body or that any specific results will be achieved. The factors
that could cause actual future results to differ materially from
current expectations include, but are not limited to, risks and
uncertainties relating to the Company’s ability to produce more
drug for clinical trials; the availability of substantial
additional funding for the Company to continue its operations and
to conduct research and development, clinical studies and future
product commercialization; and, the Company’s business, research,
product development, regulatory approval, marketing and
distribution plans and strategies. These and other factors are
identified and described in more detail in the Company’s filings
with the Securities and Exchange Commission, including the
Company’s Annual Report on Form 10-K, the Company’s Quarterly
Reports on Form 10-Q and the Company’s Current Reports on Form 8-K.
The Company assumes no obligation to update any forward-looking
statements in order to reflect any event or circumstance that may
arise after the date of this release.
INmune Bio Contact:
David Moss, CFO (858)
964-3720info@inmunebio.com
Investor Contact:
Jason NelsonCore IR(516) 842-9614 x-823
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